Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coulter Corp. — Predicate Candidate Screening
51 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
189 days90th percentile
51clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993356 | COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES | Coulter Corp. | 2000-04-20 | 197 | 0 |
| K991070 | COULTER Z2 ANALYZER | Coulter Corp. | 1999-05-11 | 41 | 0 |
| K990327 | RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS | Coulter Corp. | 1999-04-26 | 83 | 0 |
| K990172 | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYT | Coulter Corp. | 1999-04-13 | 84 | 1 |
| K990352 | COULTER AC T DIFF 2 ANALYZER | Coulter Corp. | 1999-04-01 | 55 | 1 |
| K984216 | IMMUNO-TROL CONTROL CELLS | Coulter Corp. | 1999-03-16 | 112 | 0 |
| K982167 | CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL AN | Coulter Corp. | 1998-11-09 | 143 | 0 |
| K982166 | CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL AN | Coulter Corp. | 1998-11-05 | 139 | 0 |
| K982172 | CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH | Coulter Corp. | 1998-09-24 | 97 | 0 |
| K973634 | COULTER AC.T DIFF ANALYZER | Coulter Corp. | 1997-10-29 | 35 | 0 |
| K971469 | COULTER ACT TRON CELL CONTROL | Coulter Corp. | 1997-06-30 | 69 | 0 |
| K964988 | COULTER AC.T SERIES ANALYZER | Coulter Corp. | 1997-03-06 | 83 | 0 |
| K963263 | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO | Coulter Corp. | 1997-01-22 | 155 | 1 |
| K962305 | CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANT | Coulter Corp. | 1997-01-06 | 203 | 0 |
| K962768 | CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANI | Coulter Corp. | 1997-01-06 | 203 | 0 |
| K964618 | CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTI | Coulter Corp. | 1996-12-23 | 69 | 0 |
| K962988 | COULTER GEN-S SYSTEM | Coulter Corp. | 1996-10-30 | 90 | 4 |
| K961278 | COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS | Coulter Corp. | 1996-07-22 | 110 | 0 |
| K954688 | FLOW-COUNT COULTER FLUOROSPHERES | Coulter Corp. | 1996-02-29 | 141 | 1 |
| K955334 | COULTER LINEARITY CONTROL | Coulter Corp. | 1996-02-08 | 80 | 0 |
| K955016 | 4C PLUS COULTER CELL CONTROL | Coulter Corp. | 1996-01-30 | 89 | 0 |
| K952308 | COULTER Z 1 | Coulter Corp. | 1995-10-06 | 142 | 0 |
| K950742 | CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL AN | Coulter Corp. | 1995-08-25 | 189 | 0 |
| K950949 | COULTER MH025A | Coulter Corp. | 1995-07-20 | 140 | 0 |
| K943967 | ONYX | Coulter Corp. | 1995-03-06 | 203 | 0 |
| K944751 | COULTER FLOW SET | Coulter Corp. | 1994-12-08 | 73 | 0 |
| K935953 | COULTER MULTI Q PREP | Coulter Corp. | 1994-03-11 | 88 | 0 |
| K930913 | COULTER MH015 (DIFFERENTIAL CELL COUNTER) | Coulter Corp. | 1993-08-23 | 182 | 0 |
| K932030 | COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY | Coulter Corp. | 1993-08-23 | 118 | 0 |
| K926124 | CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON | Coulter Corp. | 1993-07-06 | 214 | 0 |
| K925344 | COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA | Coulter Corp. | 1993-01-21 | 91 | 0 |
| K923421 | COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY | Coulter Corp. | 1992-09-23 | 72 | 0 |
| K914486 | COULTER CARBON DIOXIDE REAGENT | Coulter Corp. | 1991-11-27 | 50 | 0 |
| K902174 | COULTER HDL - CHOLESTEROL REAGENT | Coulter Corp. | 1990-07-31 | 78 | 0 |
| K902172 | COULTER CREATININE REAGENT | Coulter Corp. | 1990-06-28 | 45 | 0 |
| K902199 | COULTER DIRECT BILIRUBIN | Coulter Corp. | 1990-06-12 | 27 | 0 |
| K902173 | COULTER SERUM IRON/UIBC REAGENT | Coulter Corp. | 1990-06-12 | 29 | 0 |
| K902229 | COULTER CARBON DIOXIDE REAGENT | Coulter Corp. | 1990-06-12 | 26 | 0 |
| K902175 | COULTER UREA NITROGEN REAGENT | Coulter Corp. | 1990-06-12 | 29 | 0 |
| K901268 | COULTER ALBUMIN REAGENT | Coulter Corp. | 1990-05-30 | 75 | 0 |
| K901267 | COULTER CK (CREATINE KINASE) REAGENT | Coulter Corp. | 1990-05-23 | 68 | 0 |
| K901266 | COULTER TOTAL BILIRUBIN REAGENT | Coulter Corp. | 1990-04-25 | 40 | 0 |
| K901264 | COULTER GAMMA-GT (GGT) REAGENT | Coulter Corp. | 1990-04-16 | 31 | 0 |
| K900230 | COULTER AMYLASE REAGENT | Coulter Corp. | 1990-04-03 | 76 | 0 |
| K900231 | COULTER CALCIUM REAGENT | Coulter Corp. | 1990-04-03 | 76 | 0 |
| K896873 | COULTER JT3 | Coulter Corp. | 1990-03-30 | 112 | 0 |
| K901265 | COULTER MAGNESIUM REAGENT | Coulter Corp. | 1990-03-29 | 13 | 0 |
| K900215 | COULTER PHOSPHORUS REAGENT | Coulter Corp. | 1990-02-08 | 22 | 0 |
| K900216 | COULTER ALP (ALK PHOS) REAGENT | Coulter Corp. | 1990-02-08 | 22 | 0 |
| K894651 | COULTER POSITIVE CONTROL CELLS | Coulter Corp. | 1989-09-13 | 51 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda